Technology for successful decentralised clinical trials

The need for change

The traditional model of clinical trials has long been characterized by patients traveling to clinical trial sites, undergoing regular in-person assessments, and adhering to strict protocols. While this approach has been effective in generating valuable clinical data, it comes with its fair share of limitations.

Firstly, patient recruitment and retention have been major challenges. Many potential participants are deterred by the burden of frequent site visits, leading to slower enrollment and high dropout rates. This not only extends the timeline for drug development but also inflates the costs.

Secondly, the COVID-19 pandemic has exposed vulnerabilities in the traditional model, with site closures and restrictions disrupting ongoing trials. The need for a more resilient and adaptable approach became evident: decentralised clinical trials.

Decentralised clinical trials: what are they?

DCTs represent a fundamental shift away from the conventional model. In a DCT, patients participate in clinical trials from the comfort of their homes or local healthcare facilities, reducing the need for frequent site visits. This patient-centric approach leverages technology to remotely collect data, monitor patients, and conduct assessments.

Key components of DCTs include:

1. Telemedicine
   Virtual visits with healthcare providers or trial coordinators, allowing for remote assessments and consultations.
2. Digital biomarkers
   Continuous data collection through wearable devices, smartphone apps, and other digital tools to monitor patients’ health.
3. E-consent
   Electronic informed consent processes that simplify enrolment and ensure participants fully understand the trial.
4. Home-based assessments
   Patients can perform certain assessments or tests at home, reducing the need for site visits.
5. Decentralised data management
   Centralised databases for storing and managing patient data securely.

The benefits of DCTs

DCTs offer a multitude of advantages for all stakeholders involved:

1. Enhanced patient participation
   By eliminating the need for frequent travel and simplifying the consent process, DCTs make clinical trials more accessible and appealing to a broader patient population.
2. Greater data accuracy
   Continuous remote monitoring and digital biomarkers provide real-time data, reducing the risk of data inaccuracies associated with infrequent site visits.
3. Faster recruitment
   DCTs often result in quicker recruitment due to their patient-friendly nature.
4. Improved retention
   Patients are more likely to stay engaged in trials when they can participate from home, reducing dropout rates.
5. Resilience to external factors
   DCTs proved their resilience during the COVID-19 pandemic by allowing trials to continue despite site closures.

The challenges of DCT

While DCTs hold immense promise, they are not without their challenges:

1. Technology accessibility
   Not all patients have access to the required technology, potentially creating disparities in trial participation.
2. Regulatory hurdles
   Navigating regulatory requirements for DCTs can be complex, but regulatory bodies are increasingly providing guidance.
3. Data privacy and security
   Protecting patient data in a remote environment is crucial and requires robust cybersecurity measures.
4. Logistics
   Managing the logistics of remote assessments, drug delivery, and site coordination can be intricate.

The role of technology

Technology is the backbone of DCTs, enabling the seamless collection of data and patient engagement. From wearable devices that monitor vital signs to telemedicine platforms that facilitate virtual visits, technology plays a pivotal role in making DCTs possible.

Additionally, data analysis tools and centralised databases allow researchers to sift through the wealth of information generated by DCTs efficiently. Artificial intelligence (AI) and machine learning algorithms can identify trends and patterns in patient data, potentially accelerating drug discovery.

The future of clinical trials

Decentralised clinical trials are ushering in a new era of clinical research. They offer hope to patients seeking innovative treatments, provide pharmaceutical companies with more efficient and cost-effective ways to develop drugs, and empower researchers with real-time, high-quality data.

As technology continues to advance and regulatory frameworks evolve, we can expect DCTs to become increasingly common. The future of clinical trials is decentralised, patient-centric, and digitally powered—a future that promises to transform healthcare and bring new treatments to those who need them most.

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